Recalls / Class II
Class IID-0852-2020
Product
Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg, 20-count bottles, Distributed by: Aurobindo Pharma USA. Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India; NDC 65862-503-20
- Brand name
- Amoxicillin And Clavulanate Potassium
- Generic name
- Amoxicillin And Clavulanate Potassium
- Active ingredients
- Amoxicillin, Clavulanate Potassium
- Route
- Oral
- NDCs
- 65862-501, 65862-502, 65862-503
- FDA application
- ANDA091569
- Affected lot / code info
- Lot #: SM8719040-A, Exp. Date 02/2021
Why it was recalled
Presence of Foreign Substance: Customer complaint of a foreign substance identified as nylon cable tie
Recalling firm
- Firm
- AuroMedics Pharma LLC
- Manufacturer
- Aurobindo Pharma Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 30432 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2020-02-07
- FDA classified
- 2020-02-19
- Posted by FDA
- 2020-02-19
- Terminated
- 2022-11-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0852-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.